Flexible surgical stapler

ABSTRACT

A flexible surgical stapler includes an adapter having a coupling assembly configured for securing the adapter assembly to a handle assembly, an elongate body extending from the coupling assembly, a first drive assembly extending through the elongate body, and a loading unit secured to a distal portion of the elongate body. The loading unit includes a firing assembly operably connected to the first drive assembly. The firing assembly includes a cycloid gear assembly for increasing an input torque from the first drive assembly to actuate the firing assembly. The flexible surgical stapler may include an introducer assembly to facilitate introduction of a stapling portion of the surgical stapler into a body cavity of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/966,130, filed Apr. 30, 2018, the entire contents of whichare incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to surgical stapler devices. Moreparticularly, the present disclosure relates to flexible circularstaplers.

Background of Related Art

Surgical staplers for performing surgical procedures within a bodycavity of a patient are known. Typically, a stapling assembly is securedto a distal portion of an elongate shaft of the surgical staplers tofacilitate introduction of the stapling assembly within the body cavity.Generally, the elongate shafts of the surgical staplers are rigid.

To facilitate introduction of a stapling assembly of a surgical stapleralong a tortuous path, it would be beneficial to have a surgical staplerhaving a flexible elongate shaft.

SUMMARY

An adapter with a flexible elongate body is provided. The adapterincludes a coupling assembly configured for securing the adapterassembly to a handle assembly, an elongate body extending from thecoupling assembly, a first drive assembly extending through the elongatebody, and a loading unit secured to a distal portion of the elongatebody. The loading unit includes a firing assembly operably connected tothe first drive assembly. The firing assembly includes a cycloid gearassembly for increasing an input torque from the first drive assembly toactuate the firing assembly.

In embodiments, the adapter assembly further includes a second driveassembly extending through the elongate body. The second drive assemblymay be configured to effect gross movement of a trocar member throughthe loading unit.

The adapter assembly may further include a third drive assemblyextending through the elongate body. The third drive assembly may beconfigured to effect fine movement of a trocar member within the loadingunit.

Embodiments of the loading unit of the adapter assembly may include anapproximation assembly. Each of the second and third drive assembliesmay be operably connected to the approximation assembly. The seconddrive assembly may include a drive screw and a push/pull cable movablysecured to the drive screw by a threaded nut. Rotation of the drivescrew may cause longitudinal movement of the push/pull cable. The trocarmember of the adapter assembly may be disposed on a distal portion ofthe push/pull cable.

The first and third drive assemblies may each include a flexiblerotatable drive shaft and an input gear disposed on a distal portion ofeach of the flexible rotatable drive shafts. The input gear of the firstdrive assembly may rotate an internally threaded gear to finely move thetrocar member relative to the loading unit. The trocar member mayinclude a threaded intermediate portion configured to engage theinternally threaded gear. Rotation of the internally threaded gear maycause longitudinal movement of the trocar member.

In embodiments, the firing assembly may further include a spider gearhaving an external thread, and a jack nut having an internal thread. Theexternal thread of the spider gear may engage the internal thread of thejack nut such that rotation of the spider gear causes longitudinalmovement of the jack nut. The firing assembly may also include a pusherassembly secured to the jack nut for ejecting staples from the loadingunit.

A surgical stapling instrument with a flexible body portion is provided.The surgical stapling instrument includes a handle assembly, an adapterassembly extending from the handle assembly, and a loading unit disposedon a distal end of the adapter assembly. The loading unit includes afiring assembly including a cycloid gear assembly for increasing aninput torque from the handle assembly to actuate the firing assembly.

Also provided is an introducer assembly for facilitating introduction ofa stapling assembly into a body cavity of a patient. The introducerassembly includes a sleeve body, a sleeve housing secured to a distalend of the sleeve body, and first and second jaw members secured to adistal end of the sleeve housing and moveable between an open conditionand a closed condition. Each of the first and second jaw membersincludes a plurality of openings configured to receive a suture when thefirst and second jaw members are in the closed condition to maintain thefirst and second jaws in the closed position.

In embodiments, each of the first and second jaw members includes aplurality of interlocking teeth. The each tooth of the plurality ofinterlocking teeth defines an opening of the plurality of openings. Inother embodiments, each of the first and second jaw members includes aplurality of overlapping tabs. Each tab of the plurality of tabs definesan opening of the plurality of openings.

A surgical stapling kit is also provided. The kit includes a handleassembly, an adapter assembly, an anvil assembly, and an introducermember. The adapter assembly includes a loading unit disposed on adistal end thereof. The loading unit includes a firing assemblyincluding a cycloid gear assembly for increasing an input torque fromthe handle assembly to actuate the firing assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the presentsurgical staplers and, together with a general description of thedisclosure given above, and the detailed description of theembodiment(s) given below, serve to explain the principles of thedisclosure, wherein:

FIG. 1 is a side perspective view of a surgical stapling deviceaccording to an embodiment of the present disclosure, the surgicalstapling device including a handle assembly, an adapter assembly havinga loading unit, and an anvil assembly;

FIG. 2 is a side perspective view of the adapter assembly shown in FIG.1;

FIG. 3 is a side perspective view of a coupling assembly of the adapterassembly shown in FIG. 2, with parts separated;

FIG. 4 is a side cross-sectional view of the adapter assembly shown inFIG. 2;

FIG. 5 is an enlarged view of the indicated area of detail in FIG. 4;

FIG. 6 is a perspective view of a loading unit of the adapter assemblyand anvil assembly shown in FIG. 1;

FIG. 7 is a side perspective view of the loading unit shown in FIG. 6,with parts separated;

FIG. 8 is an enlarged view of the indicated area of detail in FIG. 4;

FIG. 9 is an end perspective view of the loading unit shown in FIG. 6,with a base member removed;

FIG. 10 is a perspective view of an eccentric gear of the loading unitshown in FIG. 6;

FIG. 11 is an end view of the eccentric gear shown in FIG. 10;

FIG. 12 is a perspective end view of the loading unit shown in FIG. 6with a base member and the eccentric gear removed;

FIG. 13 is an end view of the loading unit shown in FIG. 6 with the basemember and eccentric gear removed;

FIG. 14 is a side view of a stapling assembly of the loading unit shownin FIG. 6, without the pusher assembly;

FIG. 15 is a cross-sectional view taken along line 15-15 shown in FIG.8;

FIG. 16 is a side perspective view of the anvil assembly shown in FIG.6, with parts separated;

FIG. 17 is an end perspective view of the loading unit shown in FIG. 6with an outer tube of the adapter assembly shown in FIG. 2 removed;

FIG. 18 is a cross-sectional view taken along line 18-18 shown in FIG.17;

FIG. 19 is a side cross-sectional view taken along line 19-19 shown inFIG. 18;

FIG. 20 is a cross-sectional view taken along line 20-20 shown in FIG.17;

FIG. 21 is a side cross-sectional view taken along line 21-21 shown inFIG. 18;

FIG. 22 is a side perspective view of an introducer according to anembodiment of the present disclosure, with a jaw assembly in a closedcondition;

FIG. 23 is a side perspective view of the introducer shown in FIG. 22,with the jaw assembly in an open position;

FIG. 24 is an enlarged view of the indicated area of detail shown inFIG. 22;

FIG. 25 is an enlarged view of the indicated area of detail shown inFIG. 23;

FIG. 26 is a top cross-sectional view taken along line 26-26 shown inFIG. 22;

FIG. 27 is a perspective view of the introducer shown in FIG. 22received about a distal end of the adapter assembly shown in FIG. 2,with the jaw assembly in the closed condition;

FIG. 28 is a perspective view of the introducer shown in FIG. 22received about the distal end of the adapter assembly shown in FIG. 2,with the jaw assembly in the closed condition;

FIG. 29 is a side perspective view of an introducer according to anotherembodiment of the present disclosure;

FIG. 30 is a perspective view of the jaw assembly of the introducershown in FIG. 29, with parts separated; and

FIG. 31 is a top cross-sectional view taken along line 31-31 shown inFIG. 29.

DETAILED DESCRIPTION

Embodiments of the present surgical staplers are described in detailwith reference to the drawings, in which like reference numeralsdesignate identical or corresponding elements in each of the severalviews. As used herein the term “distal” refers to that portion of theadapter assembly or surgical stapler, or component thereof, farther fromthe user, while the term “proximal” refers to that portion of theadapter assembly or surgical device, or component thereof, closer to theuser. As used herein the term “user” will refer to a surgeon, aclinician, or other operating room personnel.

The surgical staplers of the present disclosures are configured tofacilitate introduction and positioning of a stapling assembly of thesurgical staplers into a body cavity of a patient through naturalorifices or incisions around contours and curvatures of the anatomywithin the patient. The introducer assemblies of the present disclosurealso facilitate introduction and positioning of the stapling assembly ofthe surgical staplers within the patient.

With reference to FIGS. 1 and 2, an adapter assembly in accordance withan embodiment of the present disclosure, shown generally as adapterassembly 100, is configured for selective connection to a poweredhandheld electromechanical instrument, shown generally as handleassembly 20. Although shown as including the powered handle assembly 20,it is envisioned that the adapter assembly 100 of the present disclosuremay be used with a manually actuated handle assembly or a roboticallycontrolled surgical system (not shown).

As illustrated in FIG. 1, the handle assembly 20 is configured forselective connection with the adapter assembly 100, and, in turn, theadapter assembly 100 is configured for selective connection with ananvil assembly 200. Collectively, the adapter assembly 100, the handleassembly 20, and the anvil assembly 200, form a surgical stapling device10. For a detailed description of the structure and function of anexemplary powered handle assembly, please refer to commonly owned U.S.Pat. No. 9,055,943 and U.S. Pat. App. Pub. No. 2016/0310134 (“the '943publication”), the content of each of which is incorporated by referenceherein in its entirety.

With continued reference to FIGS. 1 and 2, the adapter assembly 100includes an elongate body 110, and a coupling assembly 120 supported ona proximal portion 110 a of the elongate body 110 for securing theelongate body 110 to the handle assembly 20. The elongate body 110includes a flexible sleeve 112 that may be formed from selectively-rigidmemory metal, semi-flexible material, bellows, and/or from any suitablematerial. The elongate body 110 further includes a mounting member 114(FIG. 3) secured within a proximal portion of the flexible sleeve 112.The mounting member 114 includes a flange 116 for engaging a handlemember 124 of the coupling assembly 120 to secure the elongate body 110of the adapter assembly 100 to the coupling assembly 120 of the adapterassembly 100. The elongate body 110 is configured to permit bendingand/or flexion of the elongate body 110 along its length such that theloading unit 160 may be selectively moved relative to the handleassembly 20 (FIG. 1) to facilitate positioning of the loading unit 160within a patient (not shown).

With additional reference to FIG. 3, the coupling assembly 120 of theadapter assembly 100 is configured to releasably secure adapter assembly100 to the handle assembly 20 (FIG. 1). As noted above, the handleassembly 20 (FIG. 1) includes a powered handle assembly 22. As willbecome apparent from the following disclosure, the handle assembly 20may include any mechanism suitable for actuating first, second, andthird drive assemblies 130, 140, 150. It is envisioned that each of thefirst, second, and third drive assemblies 130, 140, 150 may be actuatedby the same drive member (not shown) of a handle assembly (not shown),or each of the first, second, and third drive assemblies 130, 140, 150may be actuated by respective first, second, and third drive members(not shown) of the handle assembly 20.

With continued reference to FIG. 3, the coupling assembly 120 of theadapter assembly 100 includes a base member 122, a first handle half 124a and a second handle half 124 b (collectively, handle member 124)mounted to the base member 122, a release button 126 operably secured tothe base member 122, and an electric connector 128 disposed within thebase member 122. The base member 122 is configured for releasableconnection to the handle assembly 20. For a detailed description of thestructure and function of an exemplary coupling assembly, please referto commonly owned U.S. Pat. App. Pub. No. 2015/0157321, the content ofwhich is incorporated by reference herein in its entirety, and thepreviously incorporated '943 publication.

The adapter assembly 100 further includes the first, second, and thirddrive assemblies 130, 140, 150, for performing first, second, and thirdfunctions. In embodiments, the first drive assembly 130 is configured toeffect gross approximation of the anvil assembly 200 relative to theloading unit 160, e.g., course clamping, the second drive assembly 140configured to effect fine approximation of the anvil assembly 200relative to the loading unit 160, e.g., fine clamping, and the thirddrive assembly 150 is configured to effect firing of the loading unit,e.g., stapling.

Still referring to FIG. 3, the first, second, and third drive assemblies130, 140, 150 include respective, first, second, and third connectormember 132 a, 142 a, 152 a configured for releasably connecting drivemembers (not shown) of the handle assembly 20 (FIG. 1) to respectivefirst, second, and third drive shafts 134, 144, 154, of the respectivefirst, second, and third drive assemblies 132, 142, 152. First and thirdbearing members 132 b, 152 b support respective first and third driveshafts 134, 154 of the first and third drive assemblies 132, 152, and asecond bearing assembly 142 b supports a drive screw 144 of the seconddrive assembly 140.

Each of the first and third drive shafts 134, 154 of the first and thirddrive assemblies 130, 150, respectively, of the adapter assembly 100extends the length of the elongate body 110 of the adapter assembly 100.More particularly, proximal portions 134 a, 154 a of the respectivefirst and second drive shafts 134, 154 operably engage the respectivefirst and second connector members 132 a, 152 a of the respective firstand third drive assemblies 130, 150, and distal portions 134 b, 154 b(FIG. 17) of the respective first and third drive shafts 134, 154support respective input gears 176, 182 (FIG. 17) of a respectiveapproximation assembly 170 (FIG. 7) and a firing assembly 180 (FIG. 7).

During actuation of the first and third drive assemblies 130, 150,rotation of the first and third connector members 132 a, 152 a,respectively, about their longitudinal axis in a first direction, e.g.,clockwise, as indicated by arrows “A” and “B”, respectively, causesrotation of the respective first and third drive shafts 134, 154 in thesame, first direction, about their respective longitudinal axis toeffect first and third functions. Conversely, rotation of the first andthird connector members 132 a, 152 a, respectively, about theirlongitudinal axis in a second direction, e.g., counter-clockwise, asindicated by arrows “C” and “D”, respectively, causes rotation of therespective first and third drive shafts 134, 154 in the same, seconddirection, about their respective longitudinal axis to effect first andthird functions. As described herein, the first and third driveassemblies 130, 150 operate to effect the fine clamping and firingfunctions, respectively, of the loading unit 160 of the adapter assembly100. Although the loading unit 160 is shown, and will be described, assecurely affixed to the elongate body 110, it is envisioned that theloading unit 160 may be at least partially releasable from the elongatebody 110 to permit reuse of the adapter assembly 100.

In embodiments, and as shown, the first and third drive shafts 134, 154of the first and third drive assemblies 130, 150, respectively, areformed as one-piece, e.g., integrally or monolithically formed, suchthat the entire first and second drive shafts 134, 154 rotate abouttheir respective longitudinal axes. Alternatively, either or both of thedrive shafts 134, 154 may include an outer sleeve (not shown) and arotatable inner shaft (not shown).

With additional reference to FIG. 5, the second drive shaft 144 of thesecond drive assembly 140 of the adapter assembly 100 is in the form ofa drive screw, and includes a proximal portion 144 a that operablyengages the second connector member 142 a of the second drive assembly140, and a threaded distal portion 144 b. In embodiments, and as shown,the threaded distal portion 144 b of the second drive shaft 144 ismaintained almost entirely within the handle member 124 of the couplingassembly 120 of the adapter assembly 100. In this manner, the threadeddistal portion 144 b of the second drive shaft 114 may be rigid withoutinterfering with the flexibility of the elongate body 110 of the adapterassembly 100. The threaded distal portion 144 b of the second driveshaft 144 supports a nut member 146. More particularly, the nut member146 defines first and second threaded throughbores 147 a, 147 b. Thethreaded portion 144 b of the second drive shaft 144 is received throughthe throughbore 147 a in a threaded manner.

In embodiments, and as shown, the second threaded throughbore 147 b ofthe nut member 146 of the second drive assembly 140 of the adapterassembly 100 receives a threaded proximal portion 148 a of a connector148 of a push/pull member 149 of the second drive assembly 140. Thethreaded engagement between the connector 148 and the push/pull member149 secures the push-pull member 149 to the nut member 146. Althoughshown including a threaded engagement, it is envisioned that the nutmember 146 and connector 148 may be secured to one another in anysuitable fashion, e.g., welding, adhesive, friction fit.

The push-pull member 149 of the second drive assembly 140 of the adapterassembly 100 includes an outer sleeve 149 a, and an inner cable 149 bslidably disposed within the outer sleeve 149 a. The outer sleeve 149 aof the push-pull member 149 may include a semi-rigid flexible sheath, ora coil spring, or any other flexible tubular member suitable fortransferring an axial force in the distal direction, e.g., pushingforce. The inner cable 149 b of the push-pull member 149 b may include awire, a cord, or any other material suitable for transferring an axialforce in a proximal direction, e.g., pulling force. In embodiments, theinner cable 149 b is a stainless steel braided cable. The outer sleeve149 a may be a spring winding wrapped around the braided cable. Both theouter sleeve 149 a and the inner cable 149 b are flexible to accommodatethe flexion of the elongate body 110 of the adapter assembly 100.

With continue reference to FIG. 5, during actuation of the second driveassembly 140, rotation of the second connector member 142 a of thesecond drive assembly 140 about its longitudinal axis in a firstdirection, e.g., clockwise, as indicated by arrow “E”, causes rotationof the second drive shaft 144 of the second drive assembly 140 about itslongitudinal axis in the same, clockwise direction. As the second driveshaft 144 of the second drive assembly 140 rotates in the clockwisedirection, threaded engagement between the nut member 146 and thethreaded distal portion 144 b of the second drive shaft 144 causeslongitudinal movement of the nut member 146 relative to the second driveshaft 140 in a distal direction, e.g., advancement, as indicated byarrow “F”.

Conversely, rotation of the second connector member 142 a of the seconddrive assembly 140 about its longitudinal axis in a second direction,e.g., counter-clockwise, as indicated by arrow “G”, through operation ofthe handle assembly 20 (FIG. 1) causes rotation of the second driveshaft 144 of the second drive assembly 140 about its longitudinal axisin the same, counter-clockwise direction. As the second drive shaft 144of the second drive assembly 140 rotates in the counter-clockwisedirection, threaded engagement between the nut member 146 and thethreaded distal portion 144 b of the second drive shaft 144 causeslongitudinal movement of the nut member 146 relative to the second driveshaft 140 in a distal direction, e.g., advancement, as indicated byarrow “H”.

With particular reference to FIGS. 6-8, the loading unit 160 of theadapter assembly 100 is supported on the distal portion 110 b of theelongate body 110 of the adapter assembly 100. The compact design of theloading unit 160 facilitates introduction of the loading unit 160 into abody cavity (not shown) of a patient (not shown). As noted above, theloading unit 160 may be integrally formed with the elongate body 110, ormay be releasably secured thereto to permit reuse of the adapterassembly 100. The loading unit 160 includes a main housing 162, asecondary housing 164 secured to the main housing 162, and a shellmember 166 received about the main and secondary housings 162, 164. Astaple cartridge 168 is supported on a distal portion of the shellmember 166 and is configured to dispense a circular array of staples “S”(FIG. 21). The staple cartridge 168 may be separable from the shellmember 166 to permit replacement of the staple cartridge 168 following astapling procedure. In this manner, the adapter assembly 100 and/or theloading unit 160 may be reused.

An approximation assembly 170 is operably supported within the main andsecondary housings 162, 164 of the loading unit 160, and is configuredfor gross and fine approximation of the anvil assembly 200 relative tothe cartridge assembly 168 of the loading unit 160. More particularly,the approximation assembly 170 includes a trocar member 172 secured tothe distal portion of the push/pull cable 149 (FIG. 8) of the seconddrive assembly 140 (FIG. 3), a trocar guide 173 for guiding the trocarmember 172 during approximation of the anvil assembly 200 relative tothe loading unit 160, and a spline tube 174 configured to secure theanvil assembly 200 to the trocar member 172 during approximation of theanvil assembly 200 relative to the loading unit 160 and during firing ofthe loading unit 160.

The trocar member 172 includes a proximal portion 172 a configured forsecured connection to the distal portion of the push/pull cable 149 ofthe second drive assembly 140. The proximal portion 172 a of the trocarmember 172 is bonded, welded, adhered, mechanically fastened,frictionally fit, or otherwise secured to the distal portion of thepush/cable 149. A distal portion 172 b of the trocar member 172 isconfigured to facilitate releasable connection with a center rodassembly 210 of the anvil assembly 200. The distal portion 172 b of thetrocar member 172 may further be configured to facilitate piercing oftissue during a stapling procedure. An intermediate portion 172 c of thetrocar member 172 is threaded to permit fine approximation of the anvilassembly 200 relative to the reload unit 160, as will be described infurther detail below.

The approximation assembly 170 of the loading unit 160 further includesan input gear 176 rotatably supported within the main housing 162 of theloading unit 160 and an internally threaded gear 178 rotatably supportedbetween the main housing 162 and the secondary housing 164, and inoperable engagement with the input gear 176. The input gear 176 isfixedly secured to a distal portion 134 b of the first drive shaft 134of the first drive assembly 130, and is configured to rotate theinternally threaded gear 178. As shown in FIG. 8, the distal portion ofthe push/pull cable 149 and the proximal portion 172 a of the trocarmember 170 are receivable through the threaded opening 178 a of theinternally threaded gear 178 such that the threaded intermediate portion172 c of the trocar member 172 engages the internally threaded gear 178in a threaded manner.

As will be described in further detail below, when the push/pull cable149 of the second drive assembly 140 is sufficiently retracted duringgross approximation of the anvil assembly 200 relative to the loadingunit 160 such that the threaded intermediate portion 172 c of the trocarmember 172 engages the internally threaded gear 178, rotation of theinternally threaded gear 178 causes fine longitudinal movement of thetrocar member 172. The pitch of the threads of the internally threadedgear 178 and the threaded intermediate portion 172 c of the trocarmember 172 and/or the rate at which the internally threaded gear 178 isrotated may be varied to adjust the fine movement of the anvil assembly200 relative to the loading unit 160. In embodiments, it is envisionedthat the internally threaded gear 178 may be replaced by one or morehelical wedges, or other suitable fine approximation mechanisms.

By positioning the components of the approximation assembly 170 withinthe loading unit 160, all of the forces are contained in the distal endof the surgical stapling device 10 (FIG. 1).

One or more sensors (not shown) may be disposed with the loading unit160 and/or the anvil assembly 200 to measure the compression forcesapplied to tissue received between a head assembly 220 of the anvilassembly 200 and the staple cartridge 168 of the loading unit 160.

The loading unit 160 further includes a firing assembly 180 operablysupported within the shell member 166 of the loading unit 160. Thefiring assembly 180 is actuated by the third drive assembly 150 of theadapter assembly 100 and effects the stapling and cutting of tissue (notshown) received between the anvil assembly 200 and the staple cartridge178 of the loading unit 160.

With particular reference to FIG. 7, the firing assembly 180 includes aninput gear 182 (FIG. 7), and an eccentric spur gear 184 in operableengagement with the input gear 182. The eccentric spur gear 184 engagesa cycloid gear 186 which is received within a ring gear 188. A bearingassembly 190 is received within the cycloid gear 186 between the cycloidgear 186 and the eccentric spur gear 184 to facilitate rotation of thecycloid gear 186 relative to the ring gear 188. A spacer 187 may bereceived about the eccentric spur gear 184. A spider screw 192 operablyengages the cycloid gear 186, and a jack nut 194 operably engages thespider screw 192. A spacer washer 193 may be received between the spiderscrew 192 and the cycloid gear 186. A pusher assembly 196, including acircular knife 198, is secured to the jack nut 194.

With reference now to FIG. 9, the input gear 182 of the firing assembly180 of the loading unit 160 (FIG. 7) is secured to the distal portion154 b (FIG. 3) of the third drive shaft 154 (FIG. 3) of the third driveassembly 150 of the adapter assembly 100. The input gear 182 engages anexternally geared proximal portion 184 a of the eccentric spur gear 184.As shown, a diameter of the externally geared proximal portion 184 a ofthe eccentric spur gear 184 is significantly larger than a diameter ofthe input gear 182. In this manner, the eccentric spur gear 184 rotatesat a slower rate than the input gear 182, thereby operating to reducethe output speed. The direction of rotation of the eccentric spur gear184 is opposite that of the input gear 182.

Turning now to FIGS. 10 and 11, the eccentric spur gear 184 of thefiring assembly 180 of the loading unit 160 includes the externallygeared proximal portion 184 a and an eccentric distal portion 184 b. Theexternally geared proximal portion 184 a is configured to engage theinput gear 182 of the firing assembly 180. With particular reference toFIG. 11, the eccentric distal portion 184 b of the eccentric spur gear184 defines a longitudinal axis “y” that is offset from a longitudinalaxis “x” of the loading unit 160 by a distance “d”. The length ofdistance “d” relates to a difference between the length of an outerdiameter “d_(o)” (FIG. 13) of the cycloid gear 186 and a length of theinner diameter “di” (FIG. 13) of the ring gear 188.

With reference now to FIGS. 12 and 13, the cycloid gear 186 is operablyreceived within the ring gear 188, and with the eccentric spur gear 184,form a cycloid gear assembly. The outer diameter “d_(o)” of the cycloidgear 186 is the distance “d” less than the inner diameter “di” of thering gear 188. As noted above, distance “d” is also the offset distanceof the longitudinal axis “y” from the longitudinal axis “x”. The bearingassembly 190 of the firing assembly 180 is received between the cycloidgear 186 and the eccentric portion 184 b of the eccentric spur gear 184(FIG. 8).

With particular reference to FIG. 13, because of the smaller outerdiameter “d_(o)” of the cycloid gear 186 relative to the inner diameter“di” of the ring gear 188, and the corresponding offset of the eccentricportion 184 b of the eccentric spur gear 186, only a portion of atoothed outer surface 186 a of cycloid gear 186 engages a toothed innersurface 188 a of ring gear 188. In this manner, rotation of theeccentric spur gear 184 (FIGS. 9-11) within the cycloid gear 186 causethe cycloid gear 186 to roll along the toothed inner surface 188 a ofthe ring gear 188. The rolling of the cycloid gear 186 within the ringgear 188 reduces the rate of rotation of the cycloid gear 186 relativeto the ring gear 188. The movement of the cycloid gear 186 relative tothe ring gear 188 further operates to multiply the input torque from thesecond drive assembly 140 (FIG. 3). The direction of rotation of thecycloid gear 186 opposite that of the eccentric spur gear 188, or in thesame direction as the input gear 182.

Although shown including a cycloid and ring gear assembly to multiplythe input torque, it is envisioned that the cycloid gear 186 and ringgear 188 may be replaced by a planetary gear assembly (not shown). For adetailed description and function of an exemplary planetary gear systemused in an adapter assembly, please refer to commonly owned U.S. Pat.App. Pub. No. 2016/0106406, the contents of which are incorporated byreference herein in their entirety.

With continued reference to FIGS. 12 and 13, the cycloid gear 186includes a plurality of openings 185 configured to receive posts 192 bthat extend proximally from base 192 a of the spider screw 192. Theopenings 185 have a diameter larger than a diameter of the posts 192 a.This arrangement operates to accommodate the difference between theconcentric rotation of the spider gear 192 relative to the longitudinalaxis “x” and the non-concentric rotation of the cycloid gear 186 causedby the eccentric rotation of the eccentric distal portion 184 b of theeccentric spur gear 184 during operation of the firing assembly 180. Inthis manner, as the cycloid gear 186 rolls about the inner surface 188 bof the ring gear 188, the oversized nature of the openings 185accommodate concentric rotation of the spider gear 192 about thelongitudinal axis “x” while the cycloid gear 186 rotation is eccentric.

With reference to FIGS. 14 and 15, the spider gear 192 of the firingassembly 180 includes the base 192 a, the plurality of proximallyextending posts 192 b, and a distally extending externally threadedflange 192 c. Although shown including four (4) posts 192 b (FIG. 13),it is envisioned that the spider gear 192 may include any number ofposts 192 b. The threaded flange 192 c of the spider gear 192 supportsthe jack nut 194. More particularly, the jack nut 194 includes athreaded inner surface 194 a that engages the threaded flange 192 c ofthe spider gear 192 such that as the spider gear 192 rotates about thelongitudinal axis “x”, the jack nut 194 is moved along the longitudinalaxis “x”, e.g., advance or retracted.

The jack nut 194 of the firing assembly 180 includes a distallyextending flange 194 b that securely engages the pusher assembly 196 ofthe firing assembly 180. In this manner, as the jack nut 194 is moved inthe distal direction, the pusher assembly 196 is also moved in thedistal direction. Conversely, when the jack nut 194 is moved in theproximal direction, the pusher assembly 196 also moves in the proximaldirection.

The pusher assembly 196 of the firing assembly 180 is substantiallysimilar to the pusher assembly described in commonly owned U.S. Pat. No.9,168,042 (“the '042 patent”), the content of which is incorporatedherein by reference in its entirety.

Referring now to FIG. 16, the anvil assembly 200 of the surgicalstapling device 10 includes a center rod assembly 210, and a headassembly 220 pivotally secured to the center rod assembly 210. Briefly,the center rod assembly 210 includes a center rod 212, a plunger member214, and a spring member 216. The head assembly 220 includes a housing222, a frangible ring 224, a backup member 226, a washer 228, a cut ring230, a retaining sleeve 232, and a cam latch member 234. For a detaileddescription of the structure and function of an exemplary anvilassembly, please refer to commonly owned U.S. Pat. No. 9,554,802, thecontent of which is incorporated herein by reference in its entirety.

The operation of the loading unit 160 of the adapter assembly 100 willnow be described with reference to FIGS. 17-21. Referring initially toFIG. 17, the first, second, and third drive assemblies 130, 140, 150terminate in the loading unit 160. More particularly, the input gear 172of the approximation assembly 170 (FIG. 7) is disposed on the distalportion 134 b of the first drive shaft 134 of the first drive assembly130 and is rotatably supported within the main housing 162 of theloading unit 160. The input gear 182 of the firing assembly 180 (FIG. 7)is disposed on the distal portion 154 b of the third drive shaft 154 ofthe third drive assembly 150 and is rotatably supported within the mainhousing 162 of the loading unit 160. The distal portion of the push/pullcable 149, and the trocar member 172 secured thereto, are receivedthrough the main housing 162 of the loading unit 160.

As discussed in detail above, the approximation of the trocar member 172is a two-step process effectuated by actuation of the second driveassembly 140 to complete gross approximation, followed by actuation ofthe first drive assembly 130 to complete fine approximation. Actuationof the second drive assembly 140 causes longitudinal movement of thepush/pull cable 149 of the second drive assembly 140, and of the trocarmember 172 of the approximation assembly 170. The second drive assembly140 is configured for gross approximation of the push/pull cable 149.More particularly, actuation of the second drive assembly 140, asdescribed above, causes retraction of the trocar member 172 and attachedanvil assembly 200 into the spine tube 174 of the approximation assembly170. Upon engagement of the intermediate portion 172 c of the trocarmember 172 with the internally threaded gear 178, the grossapproximation of the anvil assembly 200 relative to the loading unit 160is complete.

As discussed in detail above, actuation of the first drive assembly 130of the surgical stapling device 10 effects fine approximation of theanvil assembly 200 of the surgical stapling device 10 relative to theloading unit 160 of the surgical stapling device 10. More particularly,actuation of the first drive assembly 130 causes rotation of the firstdrive shaft 134, which rotates the input gear 172 of the approximationassembly 170. Rotation of the input gear 172 in a first direction, e.g.,clockwise, as indicated by arrow “M” in FIG. 19, rotates the internallythreaded gear 178 of the approximation assembly in a second direction,e.g., counter-clockwise, as indicated by arrow “N” in FIG. 19.

As the internally threaded gear 178 of the approximation assembly 170 isrotated in the first direction, the threaded engagement between theinternally threaded gear 178 and the threaded intermediate portion 172 cof the trocar guide 172 results in fine movement of the trocar member172 in the proximal direction, as indicated by arrow “L” in FIG. 18, topermit the capture of tissue between the housing 212 of the headassembly 210 of the anvil assembly 200 and the cartridge assembly 168 ofthe loading unit 160. More particularly, fine approximation of thetrocar member 172 enables a user to approximate the anvil assembly 200relative to the loading unit 160 to compress tissue therebetween untilan optimum compression is achieved. As noted above, the approximationassembly 170 is configured such that the forces contained within thedistal end of the surgical stapling device 10 (FIG. 1).

One or more sensors (not shown) in the anvil assembly 200, loading unit260, and/or along the first drive assembly 130 provide feedback to thehandle assembly 20 to actuate the first drive assembly 130 to cause fineapproximation of the anvil assembly 200 until the desired tissuecompression is achieved.

As discussed in detail above, actuation of the third drive assembly 150of the surgical stapling device 10 effects actuation of the firingassembly 180 (FIG. 7) of the loading unit 160. More particularly,actuation of the third drive assembly 150 causes rotation of the thirddrive shaft 154, which rotates the input gear 182 of the firing assembly180. Rotation of the input gear 182 in a first direction, e.g.,clockwise, as indicated by arrow “O” in FIG. 20, rotates the eccentricspur gear 184 of the firing assembly 180 in a second direction, e.g.,counter-clockwise, as indicated by arrow “P” in FIG. 19, which, asdescribed in detail, causes the rotation of the cycloid gear 190 in thefirst direction, e.g., clockwise, as indicated by arrow “Q” in FIG. 20.As also described in detail below, the rate of rotation of each of theinput gear 182, the eccentric spur gear 184, and the cycloid gear 190reduces progressively through the loading unit 160. Additionally, theeccentric spur gear 184, cycloid gear 186, and ring gear 188 operatetogether to multiply the input torque that is passed through the thirddrive assembly 150.

With particular reference now to FIG. 21, as the cycloid gear 190 turnsin a clockwise direction, as indicated by arrow “Q” in FIG. 20, thespider gear 192 turns in a clockwise direction, as indicated by arrow“R” in FIG. 21. Rotation of the spider gear 192 in the clockwisedirection causes the jack nut 192 to move in a distal direction, asindicated by arrows “T”, thereby moving the pusher assembly 196 to causethe ejection of staples “S” from the staple cartridge 168 and into thehead assembly 220 of the anvil assembly 200.

In embodiments, and as shown, the knife 198 of the firing assembly 180is secured to the pusher assembly 196. The advancement of the pusherassembly 196 causes advancement of the knife 198. In this manner, tissue(not shown) disposed between the head assembly 220 of the anvil assembly200 and the staple cartridge 168 of the loading unit 100 and within astapling surface of the housing 222 of the head assembly 220 is cutsimultaneous with, or immediately following the stapling of tissue (notshown) between the stapling surface of the housing 222 and the staplecartridge 168.

Following the stapling of tissue (not shown), the third drive assembly150 (FIG. 3) of the handle assembly 20 (FIG. 3) may be actuated inreverse to cause the retraction of the pusher assembly 196.Alternatively, the pusher assembly 196 may remain in a distal position(not shown), subsequent to the stapling of tissue. The first driveassembly 130 of the handle assembly 20 is actuated in reverse to causean initial or fine movement of the trocar member 172 of theapproximation assembly 170 in the distal direction. Once the threadedportion 172 c of the trocar member 172 disengages from the internallythreaded gear 178 of the approximation assembly 170, the second driveassembly 140 may be actuated in reverse to cause the gross movement ofthe trocar member 172 of the approximation assembly 170 to permit therelease of the anvil assembly 200 from the trocar member 172 of theapproximation assembly 170.

Turning now to FIGS. 22-28, an introducer for introducing a stapling endeffector, e.g., loading unit 160 of surgical stapling device 10,according to an embodiment of the present disclosure is shown generallyas introducer assembly 300. The introducer assembly 300 may be providedseparate from the adapter assembly 100 described hereinabove, or as partof a kit. The introducer assembly 300 includes a sleeve body 310, asleeve housing 320 disposed on a distal portion 310 b of the sleeve body310, and a pair of jaw members 330 a, 330 b secured to a distal portion320 b of the sleeve housing 320.

The sleeve body 310 is configured to be received about the elongate body110 of adapter assembly 100 of the surgical stapling device 10, and thesleeve housing 320 is configured to be received about the loading unit160 secured to the elongate body 110 of the surgical stapling device 10.The sleeve body 310 may be formed from an elastic material that permitsflexion of the elongate body 110 of the adapter assembly. The elasticityof the sleeve body 310 may further permit receipt of the loading unit160 therethrough. The sleeve housing 320 may be formed of the sameflexible material as the sleeve body 310, or may instead be formed of adifferent material. The sleeve housing 320 may be formed a more rigidmaterial than the sleeve body 310.

With particular reference now to FIGS. 24-26, the first and second jawmembers 330 a, 330 b collectively form a substantially conical bodyportion 330 when the first and second jaw members 330 a, 330 b are in aclosed condition (FIG. 22), and define an opening 331 when the first andsecond jaw members 330 a, 330 b are in a closed condition. Each of thefirst and second jaw members 330 a, 330 b is pivotally secured to adistal portion 320 b of the sleeve housing 320. Each of the first andsecond jaw members 330 a, 330 b may be secured to the sleeve housing 320with a living hinge, pivot pins (not shown), or in any other suitablemanner. In embodiments, the first and second jaw members 330 a, 330 bare biased to the open condition. Alternatively, the first and secondjaw members 330 a, 330 b may be permitted to pivot freely with respectto the sleeve housing 320 of the introducer assembly 300.

Each of the first and second jaw members 330 a, 330 b of the introducerassembly 300 includes a plurality of interlocking teeth 332 a, 332 b,respectively. At least two teeth of each of the plurality ofinterlocking teeth 332 a, 332 b of the respective first and second jawmembers 330 a, 330 b define a transvers opening 331 a, 331 b,respectively, for receiving a suture 340. More particularly, withreference to FIG. 26, the suture 440 extends from external a proximalportion 310 a of the sleeve body 310 distally through the sleeve body310 and the sleeve housing 320, and through the openings in each of theinterlocking teeth 332 a, 332 b, of the pair of jaw members 330 a, 330b, respectively, when the pair of jaw members 330 a, 330 b is in theclosed position. Receipt of the suture 340 through the openings 331 inthe first and second jaw members 330 a, 330 b secures the first andsecond jaw members 330 a, 330 b in the closed condition.

With continued reference to FIG. 26, the suture 440 extends back throughthe sleeve housing 320 and the sleeve body 310, and extends out of theproximal portion 310 a of the sleeve body 310. In this manner, first andsecond portions 340 a, 340 b of the suture 340 are received external ofthe sleeve body 310. Alternatively, either or both of the sleeve body310 and sleeve housing 320 may define longitudinal channels (not shown)for receiving the suture 440 therethrough.

Referring now to FIG. 27, the introducer assembly 300 is shown receivedabout the loading unit 160 and the distal portion 110 b of the elongatebody 110 of the adapter assembly 100. The pair of jaw members 330 a, 330b of the introducer assembly 300 is secured in the closed condition bysuture 340 (FIG. 25). In this closed condition, the introducer assembly300 facilitates insertion of the loading unit 160 into a body cavity(not shown) of a patient (not shown). The flexible nature of the sleevebody 310 accommodates the receipt of the loading unit 160 along tortuouspaths, e.g., through sections of an intestine.

Turning now to FIG. 28, when the loading unit 160 of the adapterassembly 100 is positioned in a desired location within the patient, thesuture 340 is withdrawn from the openings 331 a, 331 b of the first andsecond jaw members 330 a, 330 b, respectively, by pulling on either ofthe first or second portion 340 a, 340 b of the suture 340. Once thesuture 340 is withdrawn from the openings 331 a, 331 b of the first andsecond jaw members 330 a, 330 b, the first and second jaw members 330 a,330 b are free to move to the open condition. As noted above, inembodiments, the first and second jaw members 330 a, 330 b are biased tothe open condition. Alternatively, the first and second jaw member 330a, 330 b may move to the open condition as the introducer is retractedrelative to the loading unit 160 of the adapter assembly 100.

As shown in FIG. 28, whether biased opened or moved to the opencondition through retraction of the introducer assembly 300 relative tothe loading unit 160, as indicated by arrow “T”, once the first andsecond jaw members 330 a, 330 b are in the open condition, theintroducer assembly 300 may be removed from about the loading unit 160and the distal portion 110 b of the elongate body 110 of the adapterassembly 100. Once the introducer assembly 300 is retracted from aboutthe loading unit 160, the surgical stapling device 10 may be used in aconventional manner, as described above.

With reference now to FIGS. 29-31, an introducer according to anotherembodiment of the present disclosure is shown generally as introducer400. The introducer 400 is substantially similar to introducer assembly300 described hereinabove, and will only be described in detail asrelates to the differences therebetween.

The introducer assembly 400 includes a sleeve body 410, a sleeve housing420 disposed on a distal portion 410 b of the sleeve body 410, and firstand second jaw members 430 a, 430 b secured to a distal portion 420 b ofthe sleeve housing 420.

The first and second jaw members 430 a, 430 b collectively form asubstantially conical body portion 430 when the first and second jawmembers 430 a, 430 b are in a closed condition (FIG. 29), and define anopening 431 when the first and second jaw members 430 a, 430 b are in aclosed condition. Each of the first and second jaw members 430 a, 430 bincludes a plurality of tabs 432 a, 432 b, respectively, that eachdefine an opening 431 a, 431 b. The tabs 432 a, 432 b of the respectivefirst and second jaw members 430 a, 430 b overlap when the first andsecond jaw members 430 a, 430 b are in the closed condition. In thismanner, a suture 440 is receivable through the openings 431 a, 431 b ofthe respective tabs 432 a, 432 b to secure the first and second jawmembers 430 a, 430 b in the closed condition. Withdrawal of the suture440 from within the openings 431 a, 431 b of the respective tabs 432 a,432 b of the respective first and second jaw members 430 a, 430 bpermits movement of the first and second jaw members to the opencondition (not shown).

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

What is claimed is:
 1. An introducer assembly for facilitatingintroduction of a stapling assembly into a body cavity of a patient, theintroducer assembly comprising: a sleeve body having proximal and distalends; a sleeve housing disposed on the distal end of the sleeve body,the sleeve housing including proximal and distal portions; and first andsecond jaw members secured to the distal portion of the sleeve housingand moveable between an open condition and a closed condition, whereineach of the first and second jaw members includes a plurality ofopenings configured to receive a suture when the first and second jawmembers are in the closed condition to maintain the first and secondjaws in the closed condition, wherein each of the first and second jawmembers includes a plurality of interlocking teeth, and wherein eachtooth of the plurality of interlocking teeth defines an opening of theplurality of openings.
 2. The introducer assembly of claim 1, whereinthe first and second jaw members are pivotally secured to the distal endof the sleeve housing.
 3. The introducer assembly of claim 1, whereinthe first and second jaw members are pivotally secured to the distal endof the sleeve housing by a living hinge.
 4. The introducer assembly ofclaim 1, wherein when the first and second jaw members are in the closedposition, the first and second jaw members form a conical member.
 5. Theintroducer assembly of claim 1, wherein the housing sleeve is configuredto receive a stapling assembly of a circular stapling instrument.
 6. Theintroducer assembly of claim 1, wherein the sleeve body is configured toreceive a sleeve of a circular stapling instrument.
 7. The introducerassembly of claim 1, wherein the first and second jaw members are biasedto the open condition.
 8. A kit comprising: an adapter assemblyincluding a loading unit disposed on a distal end thereof, the loadingunit including a firing assembly; and an introducer member according toclaim
 1. 9. The kit of claim 8, further including a handle.
 10. The kitof claim 9, further including an anvil assembly.
 11. The kit of claim 8,wherein the sleeve housing of the introducer member is configured toreceive the loading unit of the adapter assembly.